BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM SYSTEM

    MDR report key: 3945425 · Received July 21, 2014

    Report

    Report Number
    3003793491-2014-00357
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    July 5, 2009
    Report Date
    July 6, 2009
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    NCX
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE IVTM SYSTEM WAS EVALUATED ONSITE. THE VEXTA PUMP MOTOR WAS REPLACED. A COMPLETE FUNCTIONAL TEST WAS PERFORMED AND PASSED. ELECTRICAL SAFETY TEST WAS PERFORMED. THE CUSTOMER DISCARDED THE VEXTA MOTOR BY MISTAKE. A TECHNICIAN AT THE CUSTOMER'S SITE DISCOVERED THAT THE PROBLEM WAS WITH THE MOTOR DRIVER PCB.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE SETTING UP THE IVTM SYSTEM FOR USE ON A PATIENT, A "PUMP FAILURE" ERROR MESSAGE OCCURRED. SEVERAL ATTEMPTS WERE AMDE TO PRIME THE START-UP KIT (SUK); HOWEVER, THE PUMP WOULD NOT TURN. CUSTOMER REVERTED TO ALTERNATIVE COOLING METHODS (NO SPECIFIC DETAILS WERE PROVIDED). THERE WAS NO HARM TO THE PATIENT AS NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425690 ZOLL IVTM SYSTEM THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1